Lancet having adjustable penetration depth

ABSTRACT

Lancet device having an adjustable penetration depth. The lancet device includes a housing, a cap for covering the housing and for positioning the lancet device relative to a skin surface, a needle holding member for holding a lancet which needle holding member is at least partially contained within the housing, a biasing element for biasing the needle holding member toward an extended position, and a trigger for releasing the needle holding member from a retracted position. The lancet device further includes a mechanism for adjusting a penetration depth of a lancet. The penetration depth adjustment mechanism may involve adjusting a travel distance of the needle holding member, wherein the mechanism is positioned within at least one of the housing and the cap during at least a portion of length of travel of the needle holding member. The penetration depth adjustment mechanism may involve adjusting a travel distance of the needle holding member by adjusting a length of the needle holding member. The penetration depth adjustment mechanism may involve aligning at least one stop of the housing with at least one protrusion of the needle holding member. The penetration depth adjustment mechanism may involve a cavity in the needle holding member for holding a lancet, wherein the cavity depth of the needle holding member is adjusted.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of No. 09/095,902, filedJun. 11, 1998. The entire disclosure of U.S. application Ser. No.09/095,902 is considered as being part of the disclosure of thisapplication, and the entire disclosure of U.S. application Ser. No.09/095,902 is expressly incorporated by reference herein in itsentirety.

The present application expressly incorporates by reference herein theentire disclosure of U.S. application Ser. No. 09/095,905, entitled"Adjustable Length Member Such as a Cap of a Lancet Device for AdjustingPenetration Depth", filed Jun. 11, 1998.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a lancet device whose penetration depthis adjustable. The lancet device is adapted to be substantiallyinexpensive to manufacture and easy and safe to use by physicallyimpaired individuals who take their own blood samples.

2. Description of Background Information

The field relating to disposable and reusable lancet devices issubstantially crowded. U.S. Pat. No. 5,464,418 to SCHRAGA, thedisclosure of which is incorporated by reference herein in its entirety,discloses a reusable lancet device having an elongate triangular housingand triangular cap segment.

Lancets which allow adjustment of the penetration depth include U.S.Pat. No. 5,318,584 to LANGE et al., the disclosure of which isincorporated by reference herein in its entirety. This documentdiscloses a blood lancet device for withdrawing blood for diagnosticpurposes. The penetration depth of this blood lancet device may beadjusted by adjusting the position of a sealing cap relative to ahousing.

U.S. Pat. No. 4,924,879 to O'BRIEN, the disclosure of which isincorporated by reference herein in its entirety, discloses a bloodlancet device. The penetration depth may be adjusted by adjusting theposition of a skin surface sensor which may be a small socket headscrew.

U.S. Pat. No. 5,613,978 to HARDING, the disclosure of which isincorporated by reference herein in its entirety, discloses anadjustable tip for a lancet device. The penetration depth of this lancetmay be adjusted by adjusting the position of an outer cylindrical sleeverelative to an inner sleeve.

U.S. Pat. No. 4,895,147 to BODICKY et al., the disclosure of which isincorporated by reference herein in its entirety, discloses a lancetinjector which includes an elongate tubular housing with a penetrationdepth selector provided thereon. Rotation of the penetration depthselector causes a control member to contact different contact edges tothereby control the distance that a lancet tip protrudes through acentral opening.

U.S. Pat. No. 1,135,465 to POLLOCK, the disclosure of which isincorporated by reference herein in its entirety, discloses a lancet.The distance that a plunger is allowed to move forward may be changed byan adjustable movement limiting or regulating collar.

Canadian Patent No. 523,078, the disclosure of which is incorporated byreference herein in its entirety, discloses a surgical device for use inthe treatment of snake bites. The surgical device includes a lance orblade whose penetration depth may be adjusted by inserting or removing astop bar from the path of the lance or blade.

SUTOR et al., "Bleeding from Standardized Skin Punctures: AutomatedTechnic for Recording Time, Intensity, and Pattern of Bleeding",A.J.C.P., Vol. 55, pp. 542-549 (May 1971), the disclosure of which isincorporated by reference herein in its entirety, discloses a Mayoautomatic lancet. A knurled thumb screw allows adjustment of depth ofcut by regulating distance between a plunger and a striking head bymeans of a millimeter scale.

Although there are several devices which allow adjustment of thepenetration depth, there are important factors relating to the safe andeffective use of lancet assemblies which have not been addressed by suchdevices. Specifically, there is a need for a lancet device having anadjustable penetration depth whose penetration depth adjustmentmechanism is reliable and difficult to accidentally change.

SUMMARY OF THE INVENTION

The present invention is directed toward a lancet device, such as areusable lancet device, to be utilized with a lancet whose penetrationdepth is adjustable.

It is an object of the present invention to provide a lancet devicewhich has an adjustable penetration depth. The penetration depth may beadjusted by adjusting the length of a needle holding member, byadjusting the length of a housing, by adjusting the position of a stop,and/or by adjusting the depth of a cavity of a proximal segment of aneedle holding member.

It is another object of the present invention to provide a lancet devicehaving a penetration depth adjustment mechanism which is containedentirely within a housing to reduce the possibility of accidentalmisadjustment of the penetration.

It is another object of the present invention to provide a lancet devicehaving a penetration depth adjustment mechanism with a simplified capconstruction.

It is an object of the present invention to provide a lancet devicewhich is substantially cost effective to manufacture due to a smallnumber of individual pieces to be put together, yet will still besubstantially safe during use.

Still another object of the present invention is to provide a lancetdevice which provides for facilitated and effective cap positioning byimpaired individuals.

Yet another object of the present invention is to provide a lancetdevice which is comfortably positionable within a user's hand and willnot roll around within a user's hand or on a flat surface.

A further object of the present invention is to provide an improvedlancet device which does not necessitate that an exteriorly exposedplunger assembly be utilized in order to position the lancet in aretracted, ready-to-use position.

Further, the device of the present invention is designed to be utilizedby individuals to do their own routine blood test such as individualswho do home monitoring of their blood such as diabetes patients. As aresult, the present invention requires precise adaptation to make iteffective yet safe for the user. As a result, the device of the presentinvention is comprised of a small number of individual pieces, therebymaking the lancet device easier and substantially more cost effective tomanufacture and provide for use by patients, without compromising any ofthe safety needs and in fact increasing the safety of use.

In accordance with one aspect, the present invention is directed to alancet device, including: a housing; a cap for covering the housing andfor positioning the lancet device relative to a skin surface; a needleholding member for holding a lancet, the needle holding member being atleast partially contained within the housing; a biasing element forbiasing the needle holding member toward an extended position; a triggerfor releasing the needle holding member from a retracted position; and atravel adjustment mechanism capable of adjusting a length of travel ofsaid needle holding member, said travel adjustment mechanism beingpositioned within at least one of said housing and said cap during atleast a portion of the length of travel of said needle holding member.The travel adjustment mechanism may be completely positioned orcompletely contained within at least one of the housing and the capduring at least a portion of the length of travel of the needle holdingmember.

In accordance with another aspect, the needle holding member comprises afirst component and a second component, and the travel adjustmentmechanism comprises a threaded connection between the first componentand the second component. The travel adjustment mechanism may furtherinclude a protruding element on one of the first component and thesecond component, and grooves on the other of the first component andthe second component, with the protruding element being capable ofengaging the grooves. The protruding element may comprise a nipple or aspring-biased ball.

In accordance with yet another aspect, the needle holding membercomprises a first component and a second component, and the traveladjustment mechanism comprises a spring-biased element on one of thefirst component and the second component, and a plurality of recesses inthe other of the first component and the second component, with thespring-biased element being capable of engaging the recesses.

In accordance with still another aspect, the needle holding membercomprises a first component and a second component, and the traveladjustment mechanism comprises grooves in one of the first component andthe second component, and a ridge on the other of the first componentand the second component, with the ridge being capable of engaging thegrooves.

In accordance with still another aspect, the needle holding membercomprises a first component and a second component, and the traveladjustment mechanism comprises grooves in one of the first component andthe second component, and at least one leaf spring on the other of thefirst component and the second component, with the at least one leafspring being capable of engaging the grooves.

In accordance with still another aspect, the housing comprises aplurality of stops, and the needle holding member comprises a protrusionfor engaging the stops one at a time. The needle holding member and thehousing may be capable of rotating relative to each other.

In accordance with another aspect, the travel adjustment mechanism ispositioned within said housing and said cap during the length of travelof said needle holding member.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing; a cap for covering the housingand for positioning the lancet device relative to a skin surface; aneedle holding member for holding a lancet, the needle holding memberbeing at least partially contained within the housing, a length of theneedle holding member being adjustable; a biasing element for biasingthe needle holding member toward an extended position; and a trigger forreleasing the needle holding member from a retracted position.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing containing at least one stop; acap for covering the housing and for positioning the lancet devicerelative to a skin surface; a needle holding member for holding alancet, the needle holding member being at least partially containedwithin the housing, the needle holding member having at least oneprotrusion for striking the at least one stop of the housing; a biasingelement for biasing the needle holding member toward an extendedposition; a trigger for releasing the needle holding member from aretracted position; and an alignment mechanism capable of aligning theat least one stop of the housing and the at least one protrusion of theneedle holding member to adjust the extended position of the needleholding member.

In accordance with another aspect, the housing comprises an upperhousing and a lower housing, and the alignment mechanism comprises athreaded connection between the upper housing and the lower housing. Theat least one stop may comprise a guide collar on the lower housing.

In accordance with still another aspect, the housing comprises an upperhousing and a lower housing, and the alignment mechanism comprises aspring between the upper housing and the lower housing to bias the lowerhousing into the upper housing, and the alignment mechanism comprises aspacer between the upper housing and the lower housing to act against abiasing force of the spring. The at least one stop may comprise a guidecollar on the lower housing.

In accordance with yet another aspect, the housing comprises an upperhousing and a lower housing, with the lower housing having the at leastone stop which comprises a plurality of stops, and the alignmentmechanism comprises a threaded connection between the upper housing andthe lower housing. The plurality of stops may comprise stops atdifferent radial and axial positions on an interior of the lowerhousing.

In accordance with another aspect, the at least one stop comprises aplurality of stops, and the alignment mechanism comprises a rotaryconnection between the housing and the needle holding member. Theplurality of stops may comprise stops at different radial and axialpositions on an interior of the housing.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing; a cap for covering the housingand for positioning the lancet device relative to a skin surface; aneedle holding member comprising a cavity having a depth for holding alancet, the needle holding member being at least partially containedwithin the housing; a biasing element for biasing the needle holdingmember toward an extended position; a trigger for releasing the needleholding member from a retracted position; and an adjustable memberdisposed within the cavity of the needle holding member for adjustingthe cavity depth of the needle holding member.

In accordance with still another aspect, the adjustable member comprisesa screw.

In accordance with yet another aspect, the needle holding membercomprises a turn key having a pinion, and the adjustable membercomprises a nail having a tail which has a rack for engaging the pinion.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing; a cap for covering the housingand for positioning the lancet device relative to a skin surface; aneedle holding member for holding a lancet, the needle holding memberbeing at least partially contained within the housing; a biasing elementfor biasing the needle holding member toward an extended position; atrigger for releasing the needle holding member from a retractedposition; and means for adjusting a penetration depth of a lancet byadjusting a travel distance of the needle holding member, the means foradjusting the penetration depth being capable of being contained withinthe housing and the cap.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing; a cap for covering the housingand for positioning the lancet device relative to a skin surface; aneedle holding member for holding a lancet, the needle holding memberbeing at least partially contained within the housing; a biasing elementfor biasing the needle holding member toward an extended position; atrigger for releasing the needle holding member from a retractedposition; and means for adjusting a penetration depth of a lancet byadjusting a length of the needle holding member.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing containing at least one stop; acap for covering the housing and for positioning the lancet devicerelative to a skin surface; a needle holding member for holding alancet, the needle holding member being at least partially containedwithin the housing, the needle holding member having at least oneprotrusion for striking the at least one stop of the housing; a biasingelement for biasing the needle holding member toward an extendedposition; a trigger for releasing the needle holding member from aretracted position; and means for adjusting a penetration depth of alancet by aligning the at least one stop of the housing and the at leastone protrusion of the needle holding member.

In accordance with another aspect, the present invention is directed toa lancet device, comprising: a housing; a cap for covering the housingand for positioning the lancet device relative to a skin surface; aneedle holding member comprising a cavity having a depth for holding alancet, the needle holding member being at least partially containedwithin the housing; a biasing element for biasing the needle holdingmember toward an extended position; a trigger for releasing the needleholding member from a retracted position; and means for adjusting apenetration depth of a lancet by adjusting the cavity depth of theneedle holding member.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of non-limitingdrawings, and wherein:

FIG. 1 is a partially exploded perspective view of the lancet device ofthe present invention.

FIG. 2 is a cross-sectional view along line 2--2 of FIG. 1.

FIGS. 3A, 3B, 3C, and 3D are isolated, cross-sectional views of thelancet device illustrating the functioning of the lancet.

FIG. 4 is an isolated view of the trigger button of the lancet device ofthe present invention.

FIG. 5 is a bottom plan view of the triangular cap segment of the lancetdevice of the present invention.

FIG. 6 is an isolated perspective view of the lancet device illustratingthe positioning of a disposable lancet therein.

FIG. 7 is an isolated cross-sectional view illustrating the positioningof the biasing element of the lancet device according to one embodimentof the present invention, wherein the needle holding member is shown inits fully extended position.

FIG. 8 is an isolated perspective view of a second embodiment of thestopper of the lancet device.

FIG. 9 is a top view of the proximal central segment of the presentinvention showing grooves for engaging a protruding element of theproximal segment.

FIG. 10 is a cross-sectional view of an embodiment for adjusting thelength of the needle holding member involving a spring-biased elementfor engaging holes.

FIG. 11 is a cross-sectional view of an embodiment for adjusting thelength of the needle holding member involving a proximal segment havinggrooves and a proximal central segment having ridges for engaging thegrooves of the proximal segment.

FIG. 12 is a cross-sectional view of an embodiment for adjusting thelength of the needle holding member involving a proximal segment havinggrooves and a proximal central segment having a pair of leaf springs forengaging the grooves of the proximal segment.

FIG. 13 is a cross-sectional view of the proximal central segment ofFIG. 12 before insertion into the proximal segment.

FIG. 14 is a cross-sectional view of an embodiment for adjusting thelength of the housing involving a threaded upper housing which engages athreaded lower housing having a guide collar for engaging a flanged endof the needle holding member, wherein the needle holding member is shownin its fully extended position.

FIG. 15 is a cross-sectional view of an embodiment for adjusting thelength of the housing involving a spring which biases an upper housingand a lower housing against a spacer, wherein the needle holding memberis shown in its fully extended position.

FIG. 16 is a cross-sectional view of an embodiment for adjusting thelength of the housing, involving a spring which biases a needle holdingmember in a retracted position and threaded members for adjusting thelength of the housing, wherein the needle holding member is shown in itsretracted position.

FIG. 17 is a cross-sectional view of an embodiment for adjusting whichstop is engaged involving a threaded upper housing which engages athreaded lower housing having a plurality of stops for engaging a fingerof a needle holding member, wherein the needle holding member is shownin its fully extended position.

FIG. 18 is a cross-sectional view of an embodiment for adjusting whichstop is engaged involving a housing having a plurality of stops and arotatable needle holding member which has a finger for engaging theplurality of stops one at a time, wherein the needle holding member isshown in its fully extended position.

FIG. 19 is a cross-sectional view of an embodiment for adjusting acavity depth involving an adjustable bottom member which is a screw.

FIG. 20 is a cross-sectional view of an embodiment for adjusting acavity depth involving an adjustable bottom member which is adjusted byuse of a rack and pinion.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the various embodiments of the presentinvention only and are presented in the cause of providing what isbelieved to be the most useful and readily understood description of theprinciples and conceptual aspects of the invention. In this regard, noattempt is made to show details of the invention in more detail than isnecessary for a fundamental understanding of the invention, thedescription taken with the drawings making apparent to those skilled inthe art how the several forms of the invention may be embodied inpractice.

Before referring to the Figures, a broad overview of preferred aspectsof the invention is provided. The lancet device includes an elongatehousing, which is preferably triangular, adapted to fit within theuser's hand. This housing includes a first end, which can be closed oropen, an open second end, and an elongate channel therein which extendsfrom the first end to the second end.

Disposed within this elongate channel is an elongate needle holdingmember. This needle holding member is movable between a cocked,retracted position and an extended position. The needle holding memberis structured to hold a disposable lancet therein, such that a pointthereof extends away from the needle holding member.

A biasing element is disposed within the housing. The biasing element isadapted to urge the needle holding member into an extended position forpenetrating a user's skin when not held in a retracted position.

According to the present invention, there are several differentembodiments for adjusting the penetration depth of the lancet, i.e., foradjusting the maximum distance which the lancet in the needle holdingmember extends out of the housing. The penetration depth may be adjustedby adjusting the length of the needle holding member, by adjusting thelength of the housing, by adjusting the position of a stop, and/or byadjusting the depth of a cavity of the needle holding member. Adjustingthe penetration depth is important because different penetration depthsare necessary to draw blood from different people due to differences inskin thickness, differences in healing time of the skin puncture,differences in pain tolerances, and differences in the amount of bloodneeded to be drawn.

Regardless of how the penetration depth is adjusted, the presentinvention includes a stopper system to prevent axial movement of theneedle holding member within the housing. Utilizing the stopper system,the needle holding member will always be retained within the channeldespite its movement from the cocked, retracted position to the extendedposition.

The needle holding member is held in the cocked, retracted position, andaccordingly a biasing element is held in a retracted, compressedposition, until released by a trigger. The trigger releases the needleholding member from the cocked, retracted position which results in animmediate movement of the needle holding member to the extended positionas a result of the functioning of the biasing element.

The lancet device also includes a cap segment, which is preferablytriangular, with an open first side and a closed second side containinga piercing opening therein. The open first side is adapted to bematingly fitted over the open second end of the housing, therebycontaining the needle holder member and disposable lancet therein. Whenin a cocked, retracted position, or after use, the needle holding memberis disposed such that the point of the disposable lancet is concealedwithin the cap segment. During use, upon release by the trigger, theneedle holding member is immediately moved to the extended positionwherein the point of the disposable lancet will momentarily extendthrough a piercing opening into a piercing position which punctures ahole in a user's skin and then retracts back beneath the cap segment.

Moreover, before referring to the Figures, the illustrated reusablelancet device is similar to that disclosed in U.S. Pat. No. 5,464,418 toSCHRAGA, the disclosure of which is herein incorporated by reference inits entirety.

FIGS. 1-9 illustrate embodiments of the present invention which involveadjusting the penetration depth of a disposable lancet by adjusting thelength of a needle holder member via a threaded connection between twosegments of the needle holder member. The reusable lancet device 10 ispreferably formed of a lightweight, rigid or semi-rigid, andsubstantially inexpensive plastic material and is adapted for use with astandard type of disposable lancet 60. The reusable lancet device 10includes primarily an elongate, substantially triangular shaped housing20. The housing 20 includes the substantially triangular shape, withslightly rounded corners, such that it will be easy to manipulate andwill not unnecessarily roll around within a user's hand, especially ifthe user is sick, old, or otherwise impaired. Although the mostpreferred shape of the housing 20 is triangular, the housing 20 may beother shapes such as round but is preferably any shape that will notroll around on a flat surface such as D-shaped, rectangular, oroctagonal.

The elongate triangular housing 20, as illustrated in FIG. 2, includes aclosed first end 22, an open second end 24, and an elongate channel 26.Further, the housing 20 is preferably molded of two halves to be joinedtogether, so as to facilitate manufacture. The elongate channel 26extends from the closed first end 22 to the open second end 24.

Slidably positioned within the channel 26 is an elongate needle holdingmember or lancet holding member 30. This needle holding member 30, whichis movable between a cocked, retracted position, illustrated in FIG. 2,and an extended position, illustrated in FIG. 3B, includes foursegments. Specifically, the needle holding member 30 is formed of adistal segment 32, a distal central segment 35, a proximal centralsegment 31, and a proximal segment 38.

The proximal segment 38 and the proximal central segment 31 cooperate toform an adjustment mechanism 70 for adjusting the length of the needleholding member 30. The length adjustment mechanism 70 involves athreaded connection between the proximal segment 38 and the proximalcentral segment 31. The proximal segment 38 includes external threads 72and the proximal central segment 31 includes internal threads 74 forengaging each other. In an alternative embodiment which is not shown inthe drawings, the threading is reversed such that the proximal segment38 has internal threading and the proximal central segment 31 hasexternal threading.

To allow the length of the needle holding member to be set at aparticular length, the threaded length adjustment mechanism includes aprotruding element 76 on the proximal segment 38 which engages grooves78 on the proximal central segment 31. The protruding element 76 isshown as a single nipple but may be more than one nipple and may be oneor more spring-biased balls in alternative embodiments.

Upon rotation of the proximal segment 38 and the proximal centralsegment 31 relative to each other about the threaded connection of thelength adjustment mechanism 70, the overall length of the needle holdingmember 30 is increased or decreased depending upon the direction ofrotation. During rotation, the protruding element 76 snaps into and outof grooves 78 such that the length of the needle holding member may befixed at a particular length by leaving the protruding element 76engaged in a particular groove 78. FIG. 9 shows how the grooves 78 andinternal threads 74 are positioned within the interior of the proximalcentral segment 31. Other techniques for setting the position ofthreaded elements may also be used to fix the length of the needleholding member 30, such as using a set screw, using washers, or usingscrews often used on bicycles which have nylon inserts for deterringrotation of the screw.

The proximal segment 38, which protrudes from the open second end 24 ofthe housing 20 is adapted to hold the disposable lancet 60 therein.Specifically, the disposable lancet 60 includes a main body 65 and apoint 61, which until use is contained within a protective cap 62. Whenused, the body 65 is inserted into a cavity 39 of the proximal segment38, as illustrated in FIG. 2, then the protective cap 62 is pulled ortwisted from the point 61. Although the cavity 39 and disposable lancet60 are shown as being round, the cavity 39 and disposable lancet 60could be any other shapes, such as square, octagonal, etc., so long asthe disposable lancet can be engaged in the cavity 39. The disposablelancet 60 is held in the proximal segment 38 such that the point 61points away from the housing and such that sliding movement of theneedle holding member 30 will result in corresponding movement of thedisposable lancet 60. As evident from the above discussion and from thedrawings, the needle holding number or lancet holding member 30 may beseparate from the disposable lancet 60, e.g., the lancet holding member30 is adapted to hold the lancet 60.

The overall sliding and axial movement of the needle holding member 30is regulated by a stopper system. In the preferred embodiment, detailedin FIG. 2, the stopper system includes a guide collar 28 disposed withinthe housing 20. The guide collar 28 is adapted to receive the distalsegment 32 of the needle holding member 30 slidably therethrough. Theneedle holding member 30 is preferably flat such that it will slidethrough the guide collar 28, but will not rotate axially therein,thereby assuring that the needle holding member 30 will remain properlyoriented when moved into its cocked, retracted position. Further, theguide collar 28 is sized to retain a flanged end 33 of the distalsegment 32 of the needle holding member 30 between the closed first end22 of the housing 20 and the guide collar 28. In this manner, inwardmovement of the needle holding member within the housing 20 is limitedby the flanged end 33 contacting the closed first end 22 of the housing20, and outward movement of the needle holding member 20 is limited bythe flanged end 33 of the distal segment 32 contacting the guide collar28. In this manner, the needle holding member 30 will be retained withinthe channel 26.

Turning to FIG. 8, an alternative embodiment of the stopper systemincludes an elongate slot 33' disposed in the distal segment 32 of theneedle holding member 30. The slot is positioned such that a peg 28"which extends from an interior of the housing 20 passes therethrough.The peg 28" remains within the elongate slot 33' at all times therebylimiting movement of the needle holding member 30 to a length of theslot 33' and assuring that the needle holding member 30 is retainedwithin the channel 26 of the housing 20. Also, positioning of the peg28" within the slot 33' will not allow axial rotation of the needleholding member 30.

Although the stopper systems of FIGS. 7 and 8 involve an interactionbetween the distal segment 32 of the needle holding member 30 and astationary element, the stopper system could involve an interactionbetween another segment of the needle holding member and a stationaryelement. For instance, the stopper system could involve interaction ofthe distal central segment 35 with an element attached to the housing20.

So as to contain and shield the exposed point 61 of the disposablelancet 60, a triangular cap segment 50 is included. The triangular capsegment 50 includes an open first side 51 and a closed second side 52.The cap segment 50 is adapted to have substantially the sameconfiguration as the housing 20 and is sized such that the open firstside 51 may be matingly fitted over the open second end 24 of thehousing 20. Of course, although the cap segment 50 is shown as beingtriangular, the cap segment 50 may be other shapes depending upon theshape of the housing 20.

Further, the open second end 24 of the housing 20 extends from a lip 25formed in the housing 20, the lip 25 being disposed such that the openfirst side 51 of the cap segment 50 slides onto the housing 20 over theopen second end 24 of the housing 20 and will abut the lip 25 providinga smooth contoured finish. The cap segment 50 will be removably fittedon the housing 20 preferably through corresponding proportioning of aninterior dimension of the open first side 51 of the cap segment 50relative to the open second end 24 of the housing 20, but alternativelyengagement ridges or a similar removable fastener system may be includedto secure the cap segment 50 on the housing 20. Other removable fastenersystems include threads, locking clips, and locking buttons.

Disposed in the closed second side 52 of the cap segment 50 is apiercing opening 53. The piercing opening 53 is positioned such thatwhen the needle holding member 30, containing a disposable lancet 60therein, is moved to its fully extended position, the point 61 of thedisposable lancet 60 will protrude through the piercing opening 53 topuncture a desired surface. FIG. 3B shows the needle holding member 30in its fully extended position with the length of the needle holdingmember 30 adjusted such that the disposable lancet 60 will strike thecap segment 50 in the fully extended position.

FIG. 3C also illustrates the needle holding member 30 in its fullyextended position. The length of the needle holding member 30, however,has been shortened such that the disposable lancet 60 does not strikethe cap segment 50 in the fully extended position. Thus, adjusting thelength of the needle holding member 30 adjusts the penetration depth ofthe disposable lancet 60.

So as to move the needle holding member 30 from its cocked, retractedposition to its fully extended position, a biasing element is included.While other types of biasing elements may be used, the biasing elementis preferably in the form of a coil spring 40 disposed about the distalsegment 32 of the needle holding member 30. Other types of springs whichmay be useful as biasing elements include leaf springs and C-springs.The spring 40 is positioned such that it will abut a flanged lip 34formed in the needle holding member 30 and will abut the housing 20.Preferable a side of the spring 40 which abuts the housing 20 will havea larger relaxed diameter than an opposite side of the spring 40. In afirst embodiment, illustrated in FIG. 2, one end of the spring 40 ispositioned to contact the guide collar 28 of the housing 20 and ispreferably embedded in an annular ridge 42 formed in the housing 20. Theopposite side of the spring 40, which abuts the needle holding member 30is preferably contained within an annular ridge 43 formed at the flangedlip 34. In the embodiment of FIGS. 1-7, the spring 40 abuts the housing20 at peg 28' which is positioned through the slot 33' in the distalsegment 32 as shown in FIG. 7. In an alternative embodiment illustratedin FIG. 8, the spring 40 abuts peg 28" which is also positioned throughthe slot 33' in the distal segment 32.

With the spring 40 positioned appropriately, when extended, the spring40 will urge the needle holding member 30 toward the open second end 24of the housing 20. When the needle holding member 30 is in itsretracted, cocked position, as detailed in FIG. 2, the spring 40 iscompressed. Once the needle holding member 30 is allowed to move to itsextended position, the spring 40 will quickly and immediately move theneedle holding member 30 to the fully extended position with the point61 of the disposable lancet 60 protruding through the piercing opening53 to puncture a desired surface. Depending upon how the length of theneedle holding member 30 is set, the disposable lancet 60 will strikethe cap segment 50, (see FIG. 3B), or will not strike the cap segment50, (see FIG. 3C), in the fully extended position.

After this initial release and movement to the fully extended position,the spring 40 relaxes such that the needle holding member 30 will moveslightly back toward the closed first end 22 of the housing 20, asillustrated in FIG. 3D, into a relaxed position wherein the point 61 ofthe disposable lancet 60 is contained within the cap segment 50 and willnot accidentally contact a user unnecessarily.

In order to hold the needle holding member 30 in its cocked, retractedposition, and subsequently allow release by a user in order to initiatemovement of the needle holding member 30 to its extended position, atrigger is included. The trigger preferably includes an aperture 29formed in the housing 20 near the open second end 24 thereof. Alsoincluded as part of the trigger is an outwardly biased engagementsegment 36 which extends from the distal central segment 35 of theneedle holding member 30. The engagement segment 36 includes a distallip segment 37 which contacts an interior of the housing 20 as theneedle holding member 30 slides within the channel 26. Contact is madedue to the outwardly biasing nature of the engagement segment 36, andwhen the needle holding member 30 is pushed into the housing 20 so as tobe in its retracted, cocked position, the distal lip segment 37 extendsupwardly into the aperture 29 formed in the housing 20 so as to contactthe housing 20 inside the aperture 29 and maintain the needle holdingmember 30 in its retracted, cocked position and the spring 40 in itscompressed position.

In order to release the needle holding member 30 from its retracted,cocked position, the engagement segment 36 must be pushed such that thedistal lip segment 37 exits the aperture 29 and the needle holdingmember 30 can move freely to its fully extended position due to thebiasing force of the spring 40. In order to push the engagement segment36, a trigger button 45 is disposed within the aperture 29. The triggerbutton 45, as detailed in FIG. 4, includes an upper section 46 whichprotrudes through the aperture 29 to an exterior of the housing 20 and aflanged base portion 47 which is disposed within the housing 20 so as toassure that the trigger button 45 does not get pushed out of the housing20 through the aperture 29. Disposed within the base 47 is a channel 48positioned such that the distal lip segment 37 of the engagement segment36 will slide therethrough and be able to engage the housing 20 withinthe aperture 29.

The reusable lancet device 10 of the present invention, as recited,includes a relatively small number of distinct pieces. The use of such asmall number of pieces enables quick and substantially inexpensivemanufacturing of the reusable lancet device 10 of the present invention,thereby making a cost effective product which can be available to thepublic without compromising safety.

During use, the needle holding member 30 is moved to its retracted,cocked position by removing the cap segment 50, placing the disposablelancet 60 within the needle holding member 30, and pushing thedisposable lancet 60 and accordingly the needle holding member 30 intothe housing 20 until the trigger engages. Once properly positioned, theprotective cap 62 can be removed from the disposable lancet 60 so as toexpose the point 61, and the cap segment 50 is replaced thereover. Dueto the triangular shape, the cap segment 50 will securely and properlyfit over the housing 20 no matter which orientation a user utilizes topush the cap segment 50 onto the housing 20. After a single use of thedisposable lancet 60, the cap 50 is removed, the disposable lancet 60 isremoved and discarded appropriately, and the reusable lancet device 10of the present invention is ready for an additional use.

When a user wishes to adjust the length of the needle holding member 30,the cap segment 50 is removed. The proximal segment 38 and the proximalcentral segment 31 are rotated relative to each other by use of thethreaded connection such that the protruding element 76 snaps into andout of grooves 78. To fix the length of the needle holding member, theuser leaves the protruding element 76 engaged in a particular groove 78.The cap segment 50 is then put back on the housing to cover the lengthadjustment mechanism 70 so that the reusable lancet device is againready for use. At this point, it should be noted that once the useradjusts the penetration depth to an appropriate depth, the penetrationdepth usually does not need to be adjusted again.

FIG. 10 shows another embodiment for adjusting the length of the needleholding member. The proximal central segment 31 is provided with aspring-biased cylindrical element 80 comprised of a protruding element82 and a spring 84. Although the spring-biased element 80 is shown asbeing cylindrical, other shapes such as square may be useful. Thespring-biased element 80 is perpendicular to an axis of the proximalcentral segment 31. Of course, the spring-biased element 80 does notneed to be exactly perpendicular to the proximal central segment 31.

The proximal segment 38 is provided with a plurality of holes 86. Theholes 86 are located at different positions with respect to the axiallength of the proximal segment 38. For example, the holes 86 may belocated at different axial and radial positions so as to form a spiraleffect about the proximal segment 38. Instead of holes 86, the proximalsegment 38 could be provided with recesses for the spring-biased element80 to engage.

The spring-biased element 80 and the holes 86 are designed to engageeach other to fix the length of the needle holding member 30. The lengthof the needle holding member 30 may be adjusted by changing the hole 86in which the spring-biased element 80 is engaged. The embodiment shownin FIG. 10 may be modified such that the proximal segment is providedwith the spring-biased element and the proximal central segment isprovided with the holes.

FIG. 11 illustrates another embodiment for adjusting the length of theneedle holding member 30. The proximal segment 38 has an interiorprovided with a plurality of grooves 90 formed by ridges 92. Theproximal segment 38, which is formed of a resilient material, also has apair of handles 94 on a distal end which can be grabbed by a user toseparate the sides having the grooves 90.

The proximal central segment 31 includes a neck 96 provided with tworidges 98. The ridges 98 are designed to engage the grooves 90 of theproximal segment 38.

The length of the needle holding member 30 is adjusted by changing thegroove 90 in which the ridges 98 of the neck 96 are engaged. Tofacilitate changing the length, a user may grab handles 94 to increasethe distance between the grooves 90.

The embodiment shown in FIG. 11 may be modified to form the ridges as asingle ridge which forms a circle about the top of the head of theproximal central segment. In this modified embodiment, the groove inwhich the ridge is engaged is changed by forcing the ridge from onegroove to another groove. Accordingly, handles are omitted from thismodified embodiment. The ridges, of course, may also number greater thantwo.

FIG. 12 shows another embodiment for adjusting the length of the needleholding member. The proximal segment 38 has an interior which isprovided with a plurality of grooves 100 formed by ridges 102.

The proximal central segment 31 has a pair of leaf springs 104 forengaging the grooves 100. Although a pair of leaf springs 104 are shown,a different number of leaf springs may be used such as one or more. Adistal end of each leaf spring is preferably provided with a pair ofbuttons 106 which allow a user to push the leaf springs 104 together.FIG. 13 shows the proximal central segment 31 as molded to show thedirection in which the leaf springs 104 are biased. Although the leafsprings 104 are shown as being made of a resilient plastic, the leafsprings may be a separate piece formed of a metal such as stainlesssteel or brass.

The length of the needle holding member 30 is adjusted by changing thegroove 100 in which the leaf springs 104 are engaged. To facilitatechanging the length, a user squeezes the leaf springs 104 togetherthrough use of buttons 106 to reduce the distance between the leafsprings 104.

In another group of embodiments, the length of the needle holding membermay be fixed and the length of the housing is adjusted to adjust thepenetration depth of the lancet. In this group of embodiments, thedevice is similar to that disclosed in U.S. Pat. No. 5,464,418 toSCHRAGA, the disclosure of which is herein incorporated by reference inits entirety, except for the housing length adjustment mechanisms asdiscussed below. Thus, in this group of embodiments, the needle holdingmember includes a distal segment, a central segment, and the proximalsegment.

FIG. 14 illustrates one embodiment for adjusting the housing length. InFIG. 14, the needle holding member 30 is shown in its fully extendedposition. The housing 20 comprises an upper housing 20A and a lowerhousing or distal member 20B. The upper housing 20A includes internalthreads 110, and the lower housing or distal member 20B includesexternal threads 112. The position of the upper housing 20A relative tothe lower housing or distal member 20B may be adjusted via rotationabout threads 110, 112.

The guide collar 28 of this embodiment is provided on the lower housingor distal member 20B. The flanged end 33 of the distal segment 32 of theneedle holding member cooperates with the guide collar in the samemanner as described above. Thus, the guide collar 28 engages the flangedend 33 provided on the needle holding member 30 to thereby limit theamount of travel or length of stroke of the needle holding member 30.Thus, the guide collar 28 of the lower housing 20A limits the extent towhich the needle holding member 30 extends in its fully extendedposition such that adjusting the position of the guide collar 28 adjuststhe penetration depth.

FIG. 15 illustrates another embodiment for adjusting the length of thehousing. In FIG. 15, the needle holding member 30 is shown in its fullyextended position. The housing 20 comprises an upper housing 20A and alower housing 20B. A spring 120 is disposed between the upper housing20A and the lower housing 20B to bias the housing 20 into a shortlength. Spacers 122 of varying lengths may be inserted between thespring-biased members of the housing 20 to set the length of the housing20 at desired lengths. The spacers 122 may be formed of most anymaterial but are preferably formed of rubber or nylon. Alternatively,the spacers may be in the form of C-clip spacers.

The lower housing 20B includes a guide collar 28 for engaging a flangedend 33 of the needle holding member 30 to thereby limit the amount oftravel of the needle holding member 30. Thus, similar to the embodimentshown in FIG. 14, adjusting the position of the guide collar 28 limitsthe extent to which the needle holding member 30 extends in its fullyextended position.

FIG. 16 illustrates an yet another embodiment for adjusting the lengthof the housing. In FIG. 16, the needle holding member 30 is shown in itsfully retracted position. The housing 20 comprises an upper housing 20A,a lower housing 20B, and a middle housing 20C. The upper housing 20Aincludes internal threads 170 which cooperate with external threads 172on the middle housing 20C for adjusting the length of the housing 20.Thus, adjusting the length of the housing involves screwing orunscrewing the lower housing 20B relative to the middle housing 20C.

Adjusting the length of the housing 20 adjusts the position of a guidecollar 174 located on the middle housing 20C. The guide collar 174 isdesigned to cooperate with a flange 176 located on the needle holdingmember 30 to thereby limit the amount of travel of the needle holdingmember 30. Thus, similar to the embodiments of FIGS. 14 and 15,adjusting the position of the guide collar 174 limits the extent towhich the needle holding member 30 extends in its fully extendedposition.

A coil spring 178 is disposed between a lower housing guide collar 180and a lock retainer 182. The lock retainer 182 includes two holes 184into which two fingers 186 of the needle holding member 30 are insertedand snapped into place. The lower housing 20B includes a cap 188 whichprovides access into the lower housing 20B. Access into lower housing20B facilitates positioning of coil spring 178 during assembly.

During assembly, the needle holding member 30 is inserted into lowerhousing 20B. After the coil spring 178 is placed around the needleholding member 30, the lock retainer is attached to the needle holdingmember 30 to hold the coil spring 178 in position. After this assembly,the cap 188 is inserted into the lower housing 20B to prevent access tothe interior of the lower housing 20B.

Once the device has been assembled, to cock the needle holding member30, the lower housing 20B is pulled out of the middle housing 20C topull the needle holding member 30 until a trigger, not shown, which issimilar to the trigger of the embodiment shown in FIGS. 1-7, engages theneedle holding member 30. Upon release of the lower housing 20B, thecoil spring 178 biases the lower housing 20B back into the middlehousing 20C.

In yet another group of embodiments, the penetration depth is adjustedby rotating the housing relative to the needle holding member to causethe needle holding member to engage different stops. The stops arearranged such that aligning the needle holding member with differentstops results in different penetration depths. In this group ofembodiments, the needle holding member may be of fixed length with adistal segment, a central segment, and a proximal segment as disclosedin U.S. Pat. No. 5,464,418 to SCHRAGA, the disclosure of which is hereinincorporated by reference in its entirety.

FIG. 17 illustrates an embodiment for adjusting the penetration depth bychanging which stop is engaged by rotating a portion of the housing 20relative to the needle holding member 30. The housing comprises an upperhousing 20A and a lower housing 20B. The upper housing 20A includesinternal threads 130, and the lower housing 20B includes externalthreads 132. The position of the upper housing 20A relative to the lowerhousing 20B may be adjusted via rotation about threads 130, 132.

The lower housing 20B includes a plurality of stops 134 for limiting thetravel of the needle holding member 30. The stops 134 are located atdifferent radial positions and at different axial positions topreferably form a spiral staircase effect on the interior of the lowerhousing 20B.

The needle holding member 30 includes a finger 136 for engaging one ofthese stops 134 at a time. Rotation of the upper housing 20A and lowerhousing 20B relative to each other causes the finger 136 of the needleholding member 30 to become aligned with different stops 134, one at atime. Since the stops 134 are located at different positions relative tothe axial length of the lower housing 20B, the amount of travel of theneedle holding member 30 is limited to different lengths. Thus, changingwhich stop engages the finger 136 of the needle holder member 30 adjuststhe extent to which the needle holding member 30 extends in its fullyextended position such that the penetration depth is adjusted.

FIG. 18 illustrates another embodiment for adjusting which stop isengaged, wherein rotation of the needle holding member relative to thehousing adjusts the penetration depth. A housing 20 includes a pluralityof stops 140 for limiting the travel of the needle holding member 30.The stops 140 are located at different radial positions and at differentaxial positions to preferably form a spiral staircase effect on theinterior of the housing 20.

The needle holding member 30 includes a finger 142 for engaging one ofthese stops 140 at a time. Rotation of the needle holding member 30relative to the housing 20 causes the finger 142 of the needle holdingmember 30 to become aligned with different stops 140, one at a time.Since the stops 140 are located at different positions relative to theaxial length of the housing 20, the amount of travel of the needleholding member 30 is limited to different lengths. Thus, changing whichstop 140 engages the finger 142 of the needle holder member 30 adjuststhe extent to which the needle holding member 30 extends in its fullyextended position to adjust the penetration depth.

In yet another group of embodiments, the reusable lancet device issimilar to that disclosed in U.S. Pat. No. 5,464,418 to SCHRAGA, thedisclosure of which is herein incorporated by reference in its entirety,and includes a needle holding member which includes a distal segment, acentral segment, and a proximal segment. In this group of embodiments,the structure of the proximal segment for holding the disposable lancetincludes a cavity. The bottom of this cavity includes a member whoselocation may be adjusted. By adjusting the location of this member, thedepth of the cavity is adjusted such that the distance which the lancetextends out of the cavity is adjusted to adjust the penetration depth.

FIG. 19 illustrates an embodiment for adjusting the cavity depth. Aproximal segment 38 of the needle holding member 30 includes a cavity150 for holding a disposable lancet 60. The shape of the cavity 150 ispreferably round, but is designed to accept a disposable lancet. Thebottom of the cavity 150 is formed by an adjustable bottom member suchas a screw 152. By screwing or unscrewing the screw 152 before thedisposable lancet 60 is placed in the cavity 150, the depth of thecavity 150 may be adjusted to change the distance that the disposablelancet 60 extends out of the cavity 150. By changing the distance thatthe disposable lancet 60 extends out of the cavity 150, the penetrationdepth is adjusted.

FIG. 20 shows another embodiment for adjusting the cavity depth. Aproximal segment 38 of the needle holding member includes a cavity 160for holding a disposable lancet 60. The preferred shape of cavity 160 isround. The bottom of the cavity 160 is formed by an adjustable bottommember which comprises a nail 162 having a tail 164 provided with a rack166. The proximal segment 38 of the needle holding member 30 alsoincludes a turn-key 168 disposed perpendicular to the nail 162, and ahead (not shown) which is exposed on the exterior of the proximalsegment 38. The turn-key 168 is a screw provided with a pinion 169 at adistal end for engaging the rack 166 of the nail 162. By rotating theturn-key 168, the location of the adjustable bottom member may bechanged to adjust the depth of the cavity 160 of the proximal segment.Changing the location of the adjustable bottom member changes thedistance that the disposable lancet 60 extends out of the cavity 160 tothereby adjust the penetration depth. Once the height of the adjustablebottom member is set appropriately, the rotational position of theturn-key 168 could be locked by changing the vertical position of theturn-key 168 such that the pinion 169 engages a surface or a notch (notshown in the drawings) of the proximal segment 38. The turn-key may alsointeract with the adjustable bottom member in other manners in whichrotational motion in one direction may be converted into translationalmotion in a perpendicular direction, such as a worm gear arrangement inwhich the turn key and the adjustable bottom member have threads whichinteract with each other.

Preferably, the components of the reusable lancet device of the presentinvention are made of plastic. Examples of desirable plastics includepolypropylene (PP), polyvinyl chloride (PVC), acrylonitrile butadienestyrene (ABS), nylon, linear polyoxymethylene-type acetal resin, e.g.,"DELRIN", and polycarbonate (PC), e.g., "LEXAN".

To assist in determining the penetration depth of the lancet, indiciacan be included on members that change position relative to each otherwhen the penetration depth is adjusted. For example, as illustrated inFIG. 1, indicia 87 and 88 can be included on proximal segment 38 andproximal central segment 31. The indica can comprise elements which canbe viewed by shape and/or color, such as reference numerals, letters,lines and geometric shapes. Moreover, the indica may be sensed by touch,such as raised elements, including braille. As illustrated, indica 87includes a line and indica 88 includes reference numerals. The referencenumerals can be numbers, such as from 0 to 5, with 0 being nopenetration to 5 being maximum penetration.

While the invention has been described in connection with certainpreferred embodiments so that aspects thereof may be more fullyunderstood and appreciated, it is not intended to limit the invention tothese particular embodiments. On the contrary, it is intended to coverall alternatives, modifications and equivalents as may be includedwithin the scope of the invention as defined by the appended claims.

What is claimed is:
 1. A lancet device, comprising:a housing containingat least one stop and having an end, the housing having a longitudinalaxis, a cap for covering the end of the housing and for positioning thelancet device relative to a skin surface; a lancet holding member forholding a lancet, the lancet holding member being separate from thelancet, the lancet holding member being at least partially containedwithin the housing, the lancet holding member having at least oneprotrusion for striking the at least one stop of the housing, the lancetholding member having a longitudinal axis; a biasing element for biasingthe lancet holding member toward an extended position, the biasingelement expanding in a direction of the longitudinal axis of the lancetholding member and pushing the lancet holding member; a trigger forreleasing the lancet holding member from a retracted position; and analignment mechanism capable of aligning the at least one stop of thehousing and the at least one protrusion of the lancet holding member toadjust the extended position of the lancet holding member.
 2. The lancetdevice of claim 1, wherein the housing comprises an upper housing and alower housing, and wherein the alignment mechanism comprises a threadedconnection between the upper housing and the lower housing.
 3. Thelancet device of claim 2, wherein the at least one stop comprises aguide collar on the lower housing.
 4. The lancet device of claim 1,wherein the housing comprises an upper housing and a lower housing, andwherein the alignment mechanism comprises a spring between the upperhousing and the lower housing to bias the lower housing into the upperhousing, and wherein the alignment mechanism comprises a spacer betweenthe upper housing and the lower housing to act against a biasing forceof the spring.
 5. The lancet device of claim 4, wherein the at least onestop comprises a guide collar on the lower housing.
 6. The lancet deviceof claim 1, wherein the housing comprises an upper housing and a lowerhousing, the lower housing having the at least one stop which comprisesa plurality of stops, and wherein the alignment mechanism comprises athreaded connection between the upper housing and the lower housing. 7.The lancet device of claim 6, wherein the plurality of stops comprisestops at different radial and axial positions on an interior of thelower housing.
 8. The lancet device of claim 1, wherein the at least onestop comprises a plurality of stops, and wherein the alignment mechanismcomprises a rotary connection between the housing and the lancet holdingmember.
 9. The lancet device of claim 8, wherein the plurality of stopscomprise stops at different radial and axial positions on an interior ofthe housing.
 10. The lancet device of claim 1, wherein the lancetholding member includes an elongated slot and the housing includes a pegextending through the elongated slot.
 11. A lancet device, comprising:ahousing having a proximal end and a distal end; a proximal cap forcovering the proximal end of the housing and for positioning the lancetdevice relative to a skin surface; a lancet holding member for holding alancet, the lancet holding member being at least partially containedwithin the housing, the lancet holding member comprising at least oneprotrusion; a biasing element for biasing the lancet holding membertoward an extended position; a trigger for releasing the lancet holdingmember from a retracted position; a distal member covering the distalend of the housing, the distal member including at least one stop forengaging the at least one protrusion of the lancet holding member; andwherein a position of the distal member relative to the lancet holdingmember is adjustable so as to allow adjustment of a position ofengagement of the at least one protrusion of the lancet holding memberwith the at least one stop of the distal member, such that a length oftravel of the lancet holding member is adjusted.
 12. The lancet deviceof claim 11, wherein the at least one protrusion of the lancet holdingmember comprises a flange.
 13. The lancet device of claim 11, whereinthe lancet holding member includes an elongated slot and the housingincludes a peg extending through the elongated slot.
 14. The lancetdevice of claim 11, wherein a portion of the distal member is positionedwithin the housing.
 15. The lancet device of claim 11, wherein thedistal member is capable of moving axially relative to the housing. 16.The lancet device of claim 11, further comprising a threaded connectionbetween the distal member and the housing.
 17. The lancet device ofclaim 16, wherein the distal member comprises external threads and thehousing comprises internal threads.
 18. The lancet device of claim 17,wherein the at least one protrusion of the lancet holding membercomprises a flange.
 19. The lancet device of claim 11, wherein the atleast one stop of the distal member is perpendicular to an axis of thehousing.
 20. The lancet device of claim 11, wherein the biasing elementcomprises a spring.
 21. The lancet device of claim 11, wherein thebiasing element abuts a flange on the lancet holding member.
 22. Thelancet device of claim 11, wherein the biasing element comprises aspring which abuts a flange on the lancet holding member.
 23. The lancetdevice of claim 11, wherein the at least one protrusion of the lancetholding member comprises a first flange,the lancet holding memberincludes an elongated slot and the housing includes a peg extendingthrough the elongated slot, the distal member is capable of movingaxially relative to the housing, and the biasing element comprises aspring which abuts a second flange on the lancet holding member.
 24. Alancet device, comprising:a housing comprising at least one stop; a capfor covering an end of the housing and for positioning the lancet devicerelative to a skin surface; a lancet holding member for holding alancet, the lancet holding member being separate from the lancet, thelancet holding member being at least partially contained within thehousing, the lancet holding member comprising at least one protrusion; abiasing element for biasing the lancet holding member toward an extendedposition; a trigger for releasing the lancet holding member from aretracted position; and wherein a position of the at least one stop ofthe housing and the lancet holding member relative to each other isadjustable so as to allow adjustment of a position of engagement of theat least one protrusion of the lancet holding member with the at leastone stop of the housing, such that a length of a stroke of the lancetholding member is adjusted.
 25. The lancet device of claim 24, whereinthe at least one protrusion of the lancet holding member comprises aflange.
 26. The lancet device of claim 24, wherein the lancet holdingmember includes an elongated slot and the housing includes a pegextending through the elongated slot.
 27. The lancet device of claim 24,wherein the biasing element comprises a spring.
 28. The lancet device ofclaim 24, wherein the biasing element abuts a flange on the lancetholding member.
 29. The lancet device of claim 24, wherein the biasingelement comprises a spring which abuts a flange on the lancet holdingmember.
 30. The lancet device of claim 24, wherein the at least oneprotrusion of the lancet holding member comprises a first flange.
 31. Alancet device, comprising:a housing having an end; a peg fixed to thehousing; a cap for covering the end of the housing and for positioningthe lancet device relative to a skin surface; a lancet holding memberfor holding a lancet, the lancet holding member being at least partiallycontained within the housing, the lancet holding member including anelongated slot for receiving the peg; a biasing element between the pegand lancet holding member for biasing the lancet holding member towardan extended position; a trigger for releasing the lancet holding memberfrom a retracted position; and wherein a length of travel of said lancetholding member is adjustable.
 32. The lancet device of claim 31, whereinthe housing comprises a first segment and a second segment.
 33. Thelancet device of claim 32, wherein a portion of the first segment of thehousing is positioned within the second segment of the housing.
 34. Thelancet device of claim 32, wherein the first segment of the housing isallowed to move axially relative to the second segment of the housing.35. The lancet device of claim 32, further comprising a threadedconnection between the first segment of the housing and the secondsegment of the housing.
 36. The lancet device of claim 32, furthercomprising external threads on the first segment of the housing andinternal threads on the second segment of the housing.
 37. The lancetdevice of claim 32, wherein the first segment of the housing comprisesat least one stop, and the lancet holding member comprises at least oneprotrusion for engaging the at least one stop of the first segment ofthe housing.
 38. The lancet device of claim 37, wherein the at least oneprotrusion of the lancet holding member comprises a flange.
 39. Thelancet device of claim 31, wherein the biasing element comprises aspring.
 40. The lancet device of claim 31, wherein the biasing elementabuts a flange on the lancet holding member.
 41. A lancet device,comprising:a housing having a proximal end and a distal end; a proximalcap for covering the proximal end of the housing and for positioning thelancet device relative to a skin surface; a distal member for coveringthe distal end of the housing; a lancet holding member for holding alancet, the lancet holding member being at least partially containedwithin the housing; a biasing element for biasing the lancet holdingmember toward an extended position; a trigger for releasing the lancetholding member from a retracted position; and a travel adjustmentmechanism capable of adjusting a length of a stroke of said lancetholding member, the travel adjustment mechanism comprising at least oneprotrusion on the lancet holding member and at least one stop on thedistal member for engaging the at least one protrusion on the lancetholding member.